Apparatus for use in fascial cleft surgery for opening an anatomic space

ABSTRACT

An apparatus for use in fascial cleft surgery adapted to perform blunt dissection between two layers of anatomically named fascia. The dissection performed by the apparatus extends to the limits of anatomic space defined by fusion of said two layers of fascia in a minimally invasive manner. The apparatus is formed of a hollow tube body member including a malleable introducing flange having a spoonbill-like shape. Further, the apparatus includes an elastic dissection balloon movably positioned within the applicator. The dissection balloon is reversibly expandable between a deflated condition and an expanded condition and is movable from a first storage position within the hollow tube body of the applicator to a position exterior thereof. The dissection balloon is formed of a chosen elastic material having a tensile strength less than the tensile strength of the points of fusion between two layers of fascia such that the dissection balloon fails prior to achieving pressures that would destroy the anatomic boundaries of the fascial cleft such that a working space is demonstrated not created. The apparatus also includes a gripping handle and introducing rod slideably positioned within said applicator for positioning said dissection balloon exterior said applicator to within an anatomic space for subsequent inflation and deflation. Finally, a fill tube extends through the hollow introducing rod to the dissection balloon and operably associated therewith for inflating and deflating the dissection balloon.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention pertains generally to the field of surgicalapparatus for opening an anatomic space. More particularly, the presentinvention pertains to surgical apparatus for use in fascial cleftsurgery for tissue dissection wherein a balloon device performs thefunction of tissue dissection in a minimally invasive manner.

[0003] 2. Description of the Prior Art

[0004] The American Cancer Society estimates that in 2001, 190,000 womenwere diagnosed with breast cancer. Approximately one in eight women inthe U.S. will develop breast cancer in their lifetime. This makes breastcancer the most common cancer among women. These statistics have madebreast cancer one of the most pressing issues in women's healthcaretoday.

[0005] The American Society of Plastic Surgeons reports a 174% increasein breast reconstruction procedures between 1992 and 2001, with 81,089women having reconstructive procedures last year. This trend shouldincrease exponentially as the baby boomer generation matriculates intothe high risk age group. In 1998 the Woman's Health and Cancer RightsAct (WHCRA) was passed. This federal law mandates insurance coverage forbreast reconstruction following mastectomy. These demographics shouldmake surgical treatment of breast cancer one of the most pressing issuesfor insurers over the next decade.

[0006] The mainstay of breast cancer therapy is surgery. Treatment fallsinto two categories: 1) breast conservation therapy—consisting of alumpectomy and axillary node dissection followed by radiation; and 2)Modified radical mastectomy.

[0007] Of the roughly 190,000 new cases of breast cancer each year,approximately 100,000 will undergo modified radical mastectomy. Breastreconstruction has long been an option for women who undergo mastectomy.Over the last twenty years this has evolved from a three stage procedureto a one step operation performed at the same time as the mastectomy.Immediate reconstruction at the same time as a skin sparing mastectomyhas been referred to as minimally invasive treatment of breast cancer.

[0008] Skin Sparing Mastectomy with Immediate Breast Reconstruction

[0009] Standard surgical treatments for breast cancer destroy theimportant connections of the skin of the breast to the chest wall. Inaddition it leaves a long scar, which covers the entire chest. Thiscreates unnecessary damage that is difficult to reconstruct. MinimallyInvasive surgical treatment of breast cancer begins with a skin-sparingmastectomy performed through a circular incision made just outside ofthe areolar border. In the skin-sparing mastectomy, the skin coveringthe breast is lifted off the breast tissue, which is removed along withthe nipple, areola, and the lymph nodes. The oncologic safety efficacyof skin-sparing mastectomy had been established in the literature withreports such as that by Schusterman out of M.D. Anderson in a report in1991 from SG&O [The Oncologic Risk of Skin Preservation at MastectomyWhen Combined With Immediate Reconstruction of the Breast, Kroll, S. S.,Schusterman, M. A. & others. Surgery, Gyn. And Obstetrics, January 1991Vol. 172, pgs 17-20.]. In this paper the authors described 100 cases ofimmediate breast reconstruction following skin-sparing mastectomies. Intheir series, the percentage of local recurrence was 1.2%, which isbetter than most standard modified radical mastectomy series.

[0010] The preservation of the skin covering the breast duringmastectomy obviates the need for tissue expanders and thus allows forcompletion of the reconstruction at the same time as mastectomy.Preservation of the attachment of the breast skin to the chest wall isan important principle of the skin-sparing technique. This is importantespecially at the inferior and lateral aspect of the breast. It is theseattachments of the skin to the chest wall, which give the breast itsaesthetic form. Additionally, blood supply through lateral perforatorsat the lateral aspect of the breast can also be preserved thus insuringthe viability of the skin flaps. Removing all of the breast tissue,without going beyond the anatomic boundaries of the breast (and thusdestroying the attachment of the skin overlying the breast to the chestwall) becomes the critical factor in this procedure. Understanding ofthe nature of fascial clefts and their application to breast anatomy isgreatly helpful in skin sparing mastectomy.

[0011] The breast gland is contained between two layers of superficialfascia. The sub glandular space is in fact a fascial cleft between thesuperficial fascia on the deep surface of the breast and the deep fasciaof the pectoralis major muscle and chest wall. This cleft has anatomicboundaries where all of these layers of fascia fuse and define thelimits of the breast. These fusion points have been referred to as the“circum-mammary ligament”. The application of fascial cleft surgery toskin sparing mastectomy performs this critical dissection in a quick,easy and accurate manner. What has yet to be developed, that the presentinvention provides for, is an instrument specifically designed forperformance of fascial cleft surgery in skin sparing mastectomies.

[0012] Once the breast specimen has been removed an empty envelope ofbreast skin remains and requires filling. This can be done in certainpatients with autologous tissue in the form of a TRAM (tummy tuck) flap.However, most patients are either poor candidate for this invasivereconstructive surgery or do not desire the lengthy recovery that isassociated with it. The majority of patients will opt to fill the voidcreated by the mastectomy with breast implants. Prior to the placementof these implants a muscle flap from the underlying pectoralis majormuscle and the latissimus dorsi muscle (from the back), is mobilized tocover the opening created by the mastectomy. The implant is placed underthe muscle, which gives a natural softness to the breast and the skinrepositioned over it. Following this a full thickness skin graft fromthe groin is placed on the top of the latissimus flap to reconstruct theareola. The back muscle is removed through an incision which runshorizontally and can be easily hidden by a bra or bathing suite. Allthis can be performed at the same operation as the mastectomy.

[0013] Because the skin overlying the breast and its attachments to thechest wall has been preserved, placement of a breast implant is arelatively straight forward procedure. For this reason it can beperformed safely and effectively at the same time as the mastectomy.These procedures are not terribly invasive and do not create a difficultrecovery. For this reason patients who are healthy without seriousmedical conditions can easily have this performed on an outpatient basis(23 hour stay). The use of minimally invasive approaches to mastectomyand immediate reconstruction reduces the number of surgeries required toone. This yields benefits to the patient and their families as well asproviders who are responsible for the cost of reconstruction.

[0014] The concept of minimally invasive surgery therefore does notrequire the use of one of the most important tool of the surgicalmovement—the endoscope. It does however require a surgical philosophy offirst doing no unnecessary harm to surrounding anatomic tissues andstructures in the process of accomplishing the surgical operationalplan. An analogy can be drawn to modern military forces which use smartbombs and high tech equipment to avoid civilian casualties and minimizefriendly fire injuries. This often involves the use of small incisionswhen compared to standard open surgery, but more importantly itminimizes unnecessary dissection that might destroy anatomic form andfunction leading to prolonged recovery or post operative disability ordeformity. Minimally invasive ventral hernia repair illustrates thisconcept nicely.

[0015] Ventral incisional hernias are known to occur following 10% ofall laparotomies. Each year 100,000 ventral hernias are repaired in theUS (with another 100,000 estimated in the rest of the world). Primaryclosure has a recurrence rate as high as 50%. This has led to the wideacceptance of repair techniques using synthetic mesh implants as patchesto cover abdominal wall defects. This however fails to restorefunctional strength of the abdominal wall and is still associated withan unacceptably high rate of recurrence (20 to 25% in most series). Meshrepairs have the additional drawback of potential devastatingentero-cutaneous fistulas and infections.

[0016] The “Components Separation” technique for ventral hernia repair,introduced by plastic surgeon, Oscar Ramirez in 1990, marked a novelapproach to this difficult clinical problem. The technique involves wideundermining of the abdominal skin to expose the surface of the anteriorabdominal wall, after standard exposure and excision of the hernia sac.Long relaxing incisions are made through anterior fascia one centimeterlateral and parallel to the semi-lunar line. Next, open blunt dissectionis performed in a fascial cleft between the layers of the externaloblique and internal oblique muscles. Dissection to the borders of thisfascial cleft allows for mobilization of the rectus muscles to themidline to achieve direct closure without tension. Midline closureobviates the need for mesh and restores proper function and strength ofthe anterior abdominal wall.

[0017] Despite dramatic reduction in recurrence rates (to single digitsin multiple published reports) several factors have prevented widespreadadoption of this procedure. First, the vast majority of reports on thistechnique have been published in the Plastic Surgery literature, while95% of ventral hernias are performed by general surgeons. Second, thewide undermining of abdominal skin and management of resulting skinexcess is outside the comfort zone of most general surgeons. In fact,ischemia of the edges of these skin flaps with resultant woundseparation and infection has been the major criticism of the Ramireztechnique. Finally, the components separation technique requires moreeffort and time, than the mesh repair, due to the need for open exposureof the anterior abdominal wall. Endoscopically assisted componentsseparation, reported first by Lowe, Rohrich, et. al. addressed theseconcerns and has shown it to be a safe and effective method of repair ofcomplicated and recurrent midline ventral hernias (Lowe J B, Garza J R,Bowman J L, Et al. Endoscopically assisted “components separation” forclosure of abdominal wall defects. Plast Reconstr Surg 2000;105:720-29).

[0018] The use of Fascial Cleft Surgery allows for quick and easyperformance of endoscopically assisted components separation repairs. Italleviates the need for undermining of skin and accomplishes dissectionof the abdominal wall components (external oblique and internal obliquemuscles), with the new surgical instrument constituting the presentinvention, to the limits of the fascial cleft. Endoscopy allows forrelease of the external oblique fascia under direct visualization. Thismaneuver is performed as quickly and easily as introduction of trocarsin laparoscopic procedures. The remainder of the procedure is reduced todirect closure of the midline defect. Attempts by Lowe and others to useexisting balloon dissectors based on the Kieturakis prior art failed todissect the fascial cleft to its anatomic borders due to limitations ofits design and the inelastic nature of the balloon. This requiredmultiple insertions of the balloon into the cleft between the externaland internal oblique muscles. It also failed to fully dissect the entireanatomic space since dissection was limited to the dimensions of thedevice. Perhaps this incomplete dissection resulted in insufficientrelease of tension when the midline was closed and accounts for thehigher recurrence of hernia formation in Lowe's endoscopic series whencompared to his open components separation repairs. This makes a strongargument for a new improved surgical device for performing minimallyinvasive ventral hernia repair with fascial cleft dissection.

[0019] Minimally Invasive Surgery

[0020] Minimally invasive surgery was born in the “fertile crescent” ofthe peritoneal cavity. Complex surgical maneuvers performed throughsmall incisions are enabled by opening the potential space that is theperitoneal cavity through gas insufflation. Gas is used to inflate theanatomic space until the anatomic boundaries are reached. Once theanatomic potential space has been opened and inflated to its limits anendoscope is inserted and the space is inspected and manipulated asnecessary. Minimally invasive procedures outside the peritoneum havedefied exploration because of the lack of an easily accessible andinflatable working space.

[0021] Bonutti, U.S. Pat. No. 5,163,949, recognized the need forretraction of soft tissues when working outside the peritoneal cavity.He envisioned cannulas and catheters that were inserted into a mass oftissue and used inflatable devices to expand perpendicular to the axisof the cannula. This created a working space when the distal end of thecannula expanded and caused separation along natural tissue planes for asubstantial distance.

[0022] A surgical balloon dissector and method of use is disclosed inU.S. Pat. No. 5,496,345, to Kieturakis et al. This device provides foran expansible tunneling apparatus that creates an anatomic work space ina body mass. It is comprised of a tubular member with a rigid tunnelingshaft having a blunt tipped obturator for tunneling through tissue to adesired location for dissection. The device contains a non-elastomericballoon designed in the shape of a mantaray. This balloon on the distalend of the shaft is positioned in the preferred embodiment behind theinguinal region in the pre-peritoneal space after being introducedthrough an incision at the umbilicus.

[0023] In Johnson et al., U.S. Pat. No. 5,258,026, Johnson embellishedBonutti's work by describing a method for dissection using a tissueexpander. He described use of a hollow endotube with a bullet shapedobturator that is used to tunnel to a desired location between skin andsubcutaneous fat, skin and bone, skin and muscle or skin and fascia. Theendotube is then used to deliver a tissue expander to the location whichis then expanded to create spaces, cavities, or pockets in the body. Herecommends overfilling the inflatable hollow member by 50%. Thepreferred embodiment of this method is a breast augmentation performedthrough an umbilical incision.

[0024] Johnson is still limited to creating spaces based on thedimensions of the device, even when the device was “overfilled by 50%”.Johnson was also imprecise in the tunneling of the endotube andpositioning of the inflatable dissector. Its method lacked asophisticated understanding of soft tissue anatomy and implied that itis practical and possible to create a dissection space at any desiredlocation or plane of tissue. This is in fact not the case. For instance,it is not possible to perform minimally invasive blunt dissection withan inflatable device within the subcutaneous fat as Johnson claims. Thisis because of the existence of anatomic entities named “verticalcutaneous ligaments” which run up vertically from superficial fascia(which is in the horizontal plane) to the skin. This anatomic constructis analogous to a honey comb filled with honey, where the fat is thehoney and the comb is the fascia and ligaments. Dissection in thisnatural plane (i.e. the subcutaneous plane) can only be preformed withsharp dissection, or a constant combination of sharp and bluntdissection as in face lift surgery. This is because the verticalcutaneous ligaments cross the horizontal subcutaneous plane and resistblunt dissection.

[0025] In Rehnke, U.S. Pat. No. 6,055,989, fascial cleft surgery wasfirst disclosed. A fascial cleft is an anatomic potential space betweenlayers of fascia throughout the body with defined limits or boundaries,much like the peritoneal cavity. Fascial cleft surgery enables minimallyinvasive endoscopic surgery outside the peritoneal cavity in all regionsof the body. Fascial cleft surgery not only respects the soft tissueanatomic layers and boundaries but takes full advantage of theirexistence. Unlike the peritoneal cavity, in laparoscopy, the potentialspace between layers of fascia has more cohesion and can not beseparated into a true working space by CO2 gas insufflation. Aspecialized dissection instrument is required. The present inventionrelates to a specialized surgical instrument for use in fascial cleftsurgery.

[0026] The patent to Bonutti, U.S. Pat. No. 5,163,949, discloses the useof cannulas to tunnel through a body mass indiscriminately and CREATES awork space in unspecified natural planes. The surgical apparatuscomprising the present invention for use in fascial cleft surgery fortissue dissection utilizes a balloon device to perform the function oftissue dissection in a minimally invasive manner. The inflatable deviceof the Bonutti apparatus determines the size of the work space andretracts tissue based on the construct of the device shape. This methoddoes nothing to delineate the size or boundaries of an underlyinganatomic space. Bonutti's method relies on the design of the instrumentrather than the inherent anatomic design of the body to create a space.

[0027] The surgical apparatus comprising the present invention uses opendissection, through a small incision, to a specific anatomic cleftbetween layers of known named fascia to enter a particular fascialcleft, which is analogous to the peritoneal cavity in laparoscopy. Theinflatable device comprising the present invention, which has nopredetermined inflated fixed shape or dimensions, is delivered into thefascial cleft without any tunneling through layers of tissue. Theinflatable balloon apparatus of the present invention is designed tofail before achieving pressures that would destroy the anatomicboundaries of the fascial cleft. The pressure generated by the expansionof the device is weaker than the integrity of the fascia and the pointsof fusion between the two layers of fascia. The working space is notcreated, it is demonstrated. This is a fundamental difference inphilosophy of dissection which requires a distinct difference in designand use of the instrument.

[0028] U.S. Pat. No. 5,496,345, to Kieturakis et al. discloses a deviceused for practicing a method of dissection. The only anatomicdistinction made is in regard to the preperitoneal space in thepreferred embodiment of inguinal hernia repair. It also creates a workspace of dimensions that follow the design of the device rather thandemonstrate existing anatomic spaces. The patent teaches a “balloon isformed of a non-elastomeric material; it is a volume-limited balloon toprevent overexpansion.” This reflects a fundamental departure from thephilosophy regarding minimally invasive soft tissue dissection. Theshape of the Kieturakis device has a non-elastic balloon of designeddimensions that creates a work space according to its fixed size. Thisis undesirable in the '989 Rehnke method of fascial cleft surgery. Thepresent invention requires an elastic device which expands until itreaches the anatomic limits of the fascial cleft.

[0029] The Kieturakis device is made of a hollow tube with a rigid shaftwith a hemispherical or ellipsoidal obturator at the end, designed totunnel through tissue. This sort of straight rigid shaft with a bulletshaped obturator is highly undesirable if one wants to keep the devicewithin a specific anatomic cleft during introduction of the inflatablemember. The Present invention comprises a flat, beveled spoonbill distalend with a malleable end ideally suited for inserting the inflatabledevice of the present invention into a fascial cleft of curvilinearproportions without straying from that space. The Kieturakis device withits rigid shaft and obturator is prone to tunneling out of a desiredfascial cleft.

[0030] In Johnson et al., U.S. Pat. No. 5,258,026, augmentation isdisclosed wherein the surgery is performed through an umbilicalincision. Johnson teaches the use of a hollow endotube with a bulletshaped nose piece for tunneling from a remote incision to a desiredlocation for creation of a space, cavity, or pocket. This method ofdissection relates to dissection of soft tissues in various regionswithin subcutaneous fat, between skin and bone, skin and muscle, or skinand fascia. It also describes dissection between fat and bone, fat andmuscle fat and fascia and peritoneum and fascia; including betweentissue and: bladder, nerves, blood vessels and muscle. This intrusiveapproach to invasive dissection generally disregards human anatomy. Itis a method groping in anatomic darkness, hoping to hit an undefinedmark. The use of a penetrating obturator for tunneling has the samedesign drawbacks of the Kieturakis device. The expander or prosthesisthat is inflated to “overfilling . . . by about 50%”, relates to breastimplants and tissue expanders. Thus this method patent advocates use ofrelatively inelastic prostheses that are “overfilled” to create apocket; as apposed to the present invention device which is completelyelastic and follows the design of the anatomic space and is stopped bythe anatomic boundaries of the fascial cleft, rather than the point 50%beyond a prescribed fill volume.

[0031] Young, U.S. Pat. No. 5,871,497, teaches a device for dissectingalong natural tissue planes to create a tissue pocket to hold the devicewhich is left in place to perform traditional tissue expansion over along term (days and months). It uses a device with a rigid base toestablish the footprint and orientation of the expansion effort. Thissort of device clearly has no use in fascial cleft surgery.

[0032] Accordingly, there is a need for improved surgical apparatus foruse in fascial cleft surgery for minimally invasive surgical dissectionto overcome the aforementioned disadvantages in the prior art.

[0033] The use of surgical dissection tools of known designs andconfigurations is known in the prior art. More specifically, balloondisectors of known designs and configurations heretofore devised andutilized for the purpose of surgical dissection through known methodsand apparatuses are known to consist basically of familiar, expected,and obvious structural configurations, notwithstanding the myriad ofdesigns encompassed by the crowded prior art which has been developedfor the fulfillment of countless objectives and requirements.

[0034] While these devices fulfill their respective, particularobjectives and requirements, the aforementioned patents do not describea surgical apparatus for use in fascial cleft surgery for tissuedissection wherein a balloon device performs the function of tissuedissection in a minimally invasive manner.

[0035] In this respect, surgical apparatus for use in fascial cleftsurgery for tissue dissection according to the present inventionsubstantially departs from the conventional concepts and designs of theprior art, and in doing so provides an apparatus primarily developed forthe purpose of utilizing a balloon device for performing the function oftissue dissection in a minimally invasive manner.

[0036] Therefore, it can be appreciated that there exists a continuingneed for a new and improved surgical apparatus for use in fascial cleftsurgery for tissue dissection which can be used for performing thefunction of tissue dissection in a minimally invasive manner. In thisregard, the present invention substantially fulfills this need.

SUMMARY OF THE INVENTION

[0037] In view of the foregoing disadvantages inherent in the knowntypes of surgical tools of known designs and configurations now presentin the prior art, the present invention provides an improved surgicalapparatus for use in fascial cleft surgery for tissue dissection whereina balloon device performs the function of tissue dissection in aminimally invasive manner.

[0038] To attain this, the present invention essentially comprises asurgical apparatus with balloon dissector. The present invention iscomprised of a plurality of components. Such components in theirbroadest context include an applicator, an elastic dissection balloonmovably positioned within said applicator, and a hollow introducing rodslideably positioned within said applicator for positioning saiddissection balloon exterior said applicator to within an anatomic spacefor subsequent inflation and deflation. Such components are individuallyconfigured and correlated with respect to each other so as to attain thedesired objective.

[0039] The present disclosure provides a surgical apparatus for use in amethod of performing any combination of the distinct functions ofdissecting, expanding, and sizing in serial order. The apparatuspreferably utilizes an elastic balloon formed of a chosen elasticmaterial having a tensile strength less than the tensile strength of thepoints of fusion between two layers of fascia such that the dissectionballoon fails prior to achieving pressures that would destroy theanatomic boundaries of the fascial cleft such that a working space isdemonstrated not created, for example, to dissect tissue layers to opena tissue pocket or working space, to provide serial tissue expansion andif necessary to thereafter size the dissected space.

[0040] A preferred method of use of the apparatus forming the presentinvention is directed to all areas outside the peritoneal cavity whereminimally invasive surgical dissection is performed using fascial cleftsurgery. Direct open dissection is performed through a minimal incisionto access the desired fascial cleft. Then the device is inserted betweenthe two layers of fascia which define the cleft. The elastic balloon isintroduced to the space and inflated until the anatomic dimensions ofthe cleft stop the dissection. The anatomy thus having been demonstratedit can be examined and sized, expanded, or surgically manipulated asdesired.

[0041] One such application which has already been described is skinsparing mastectomy. In this case the device is used on the chest todissect the retro mammary fascial cleft and demonstrate the extent,size, and exact location of the anatomic boundaries of the breast. Theseare critical steps in the performance of this minimally invasiveprocedure.

[0042] A second application in the abdominal wall makes use of fascialcleft surgery in performing endoscopically assisted ventral herniarepair. A technique known as components separation technique requiresseparation of the outer layer of the abdominal wall from the two innerlayers to allow advancement of the attached rectus muscle for closure ofthe midline without tension. This technique repairs ventral herniaswithout the use of mesh on lays or inlays. Traditional open techniquesrequire extensive undermining of skin to expose the anterior abdominalwall so that open dissection of the fascial cleft, between the lateralabdominal wall muscles, can be bluntly dissected to their anatomicboundaries at the lumbar region. This destroys the circulation of bloodto the skin edges of the open wound and leads to a high incidence ofwound complications. A minimally invasive approach uses a small incisionover the lateral abdominal wall and performs a minimal open dissectiondown to the fascial cleft between the lateral abdominal wall muscles.The present invention provides for introduction of an elastic inflatabledissector into this fascial cleft which is inflated until dissectionreaches the anatomic limits of the cleft. The balloon can be left inplace in the expanded condition for a period of time during theprocedure to perform immediate tissue expansion prior to release of thefascia, lateral to the rectus muscles, prior to advancement to themidline for closure. This illustrates the ability to perform complexsoft tissue surgery without unnecessary collateral damage to theabdominal wall skin and its circulation.

[0043] There has thus been outlined, rather broadly, the more importantfeatures of the invention in order that the detailed description thereofthat follows may be better understood and in order that the presentcontribution to the art may be better appreciated. There are, of course,additional features of the invention that will be described hereinafterand which will form the subject matter of the claims appended hereto.

[0044] In this respect, before explaining at least one embodiment of theinvention in detail, it is to be understood that the invention is notlimited in its application to the details of construction and to thearrangements of the components set forth in the following description orillustrated in the drawings. The invention is capable of otherembodiments and of being practiced and carried out in various ways.Also, it is to be understood that the phraseology and terminologyemployed herein are for the purpose of descriptions and should not beregarded as limiting.

[0045] As such, those skilled in the art will appreciate that theconception, upon which this disclosure is based, may readily be utilizedas a basis for the designing of other structures, methods and systemsfor carrying out the several purposes of the present invention. It isimportant, therefore, that the claims be regarded as including suchequivalent constructions insofar as they do not depart from the spiritand scope of the present invention.

[0046] It is therefore an object of the present invention to provide anew and improved surgical apparatus for use in fascial cleft surgery fortissue dissection wherein a balloon device performs the function oftissue dissection which has all of the advantages of the prior art ofknown designs and configurations and none of the disadvantages.

[0047] It is another object of the present invention to provide a newand improved balloon dissection apparatus which may be easily andefficiently manufactured and marketed.

[0048] Lastly, it is an object of the present invention to provide a newand improved surgical apparatus for use in fascial cleft surgery adaptedto perform blunt dissection between two layers of anatomically namedfascia wherein the dissection extends to the limits of anatomic spacedefined by fusion of said two layers of fascia in a minimally invasivemanner. The apparatus comprises an applicator formed of a hollow tubebody member having an open proximal end and an open distal end. Furtherincluded is a spoonbill-like shaped malleable introducing flange formedat the distal end of the applicator. An elastic dissection balloon ismovably positioned within the applicator adjacent the introducingflange. The dissection balloon is reversibly expandable between adeflated condition and an expanded condition and is movable from a firststorage position within the hollow tube body of the applicator to aposition exterior thereof. Also, wherein the dissection balloon isformed of a chosen elastic material having a tensile less than thetensile strength of the points of fusion between two layers of fasciasuch that the dissection balloon fails prior to achieving pressures thatwould destroy the anatomic boundaries of the fascial cleft such that aworking space is demonstrated not created. A gripping handle is coupledto the applicator at the open proximal end thereof. The gripping handleincludes a thumb engaging recess corresponding to the introducing flangefor allowing a user to judge the orientation of the introducing flangeduring use of the apparatus. A hollow introducing rod is slideablypositioned within the applicator. The introducing rod has a first endterminating in a concave surface positioned adjacent the dissectionballoon for positioning the dissection balloon exterior the applicatorto within an anatomic space for subsequent inflation and deflation.Finally, a fill tube extends through the hollow introducing rod to thedissection balloon and operably associated therewith for inflating anddeflating the dissection balloon.

[0049] These together with other objects of the invention, along withthe various features of novelty which characterize the invention, arepointed out with particularity in the claims annexed to and forming apart of this disclosure. For a better understanding of the invention,its operating advantages and the specific objects attained by its uses,reference should be had to the accompanying drawings and descriptivematter in which there is illustrated preferred embodiments of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0050] The invention will be better understood and objects other thanthose set forth above will become apparent when consideration is givento the following detailed description thereof. Such description makesreference to the annexed drawings wherein:

[0051]FIG. 1 is an top plan view of the surgical apparatus for use infascial cleft surgery forming the present invention having thedissection balloon in a first storage position.

[0052]FIG. 1a is an top plan view of the introducing rod componentthereof.

[0053]FIG. 2 is a top plan view thereof showing the dissection balloonin a semi-deployed position.

[0054]FIG. 3 is a section taken along line 3-3 of the surgical apparatusfor use in fascial cleft surgery forming the present invention.

[0055]FIG. 4 is an enlarged view of the introducing flange as indicatedby the numeral 4 in FIG. 1 of the present invention.

[0056]FIG. 5 is a cross-sectional view of anatomical tissue forming afascial cleft.

[0057]FIG. 6 shows the surgical apparatus for use in fascial cleftsurgery in use being inserted into an incision.

[0058]FIG. 7 shows the surgical apparatus for use in fascial cleftsurgery being introduced into a fascial cleft and the dissection bagbeing introduced therein.

[0059]FIG. 8 shows the inflation of the dissection balloon within afascial cleft.

[0060] The same reference numerals refer to the same parts throughoutthe various Figures.

DESCRIPTION OF THE PREFERRED EMBODIMENT

[0061] With reference now to the drawings thereof, the preferredembodiment of the new and improved surgical apparatus for use in fascialcleft surgery for tissue dissection wherein a balloon device performsthe function of tissue dissection in a minimally invasive mannerembodying the principles and concepts of the present invention andgenerally designated by the reference numeral 10 will be described.

[0062] The present invention, the surgical apparatus 10, is comprised ofa plurality of components. See FIG. 1. Such components in their broadestcontext include an applicator, an elastic dissection balloon movablypositioned within said applicator and a hollow introducing rod slideablypositioned within said applicator for positioning said dissectionballoon exterior said applicator to within an anatomic space forsubsequent inflation and deflation. Such components are individuallyconfigured and correlated with respect to each other so as to attain thedesired objective.

[0063] The surgical apparatus comprising the present invention is foruse in fascial cleft surgery and is adapted to perform blunt dissectionbetween two layers of anatomically named fascia 12. The dissectionextends to the limits of anatomic space defined by fusion of said twolayers of fascia in a minimally invasive manner. In certain areas of thebody, points of fusion between layers of fascia create well-definedboundaries which may be used to advantage by the surgeon duringdissection, particularly balloon dissection, to create an anatomicallywell-defined space between layers joined by such ligaments 14. Ligamentswhich create such useful boundaries, for example, in: the chest andbreast, between the layers of the abdominal wall, in the upper and lowerextremities, in the back, and in the head and neck. See FIGS. 5-8.

[0064] The apparatus includes an applicator 20 as shown in FIG. 1. Theapplicator is formed of a hollow tube body member 22 and has an openproximal end 24 and an open distal end 26. The applicator forms the mainhousing of the present invention.

[0065] Further, the present invention includes a malleable introducingflange 30. The introducer flange is formed at the distal end of theapplicator. The introducer flange has a spoonbill-like shape. In use,the flange serves to spread tissue and position the distal end of theapplicator with a space defined by a fascial cleft. As an alternateembodiment, the introducer flange is malleable for allowing usermodification corresponding to individual anatomy.

[0066] Next, the surgical apparatus includes an elastic dissectionballoon 40. The dissection balloon is movably positioned within theapplicator at the distal end thereof adjacent the introducing flange.The dissection balloon is reversibly expandable between a deflatedcondition and an expanded condition. Further, the dissection balloon ismovable from a first storage position within the hollow tube body of theapplicator to a second position exterior thereof as shown in FIGS. 1 and2. Once the balloon is exterior the applicator it may be inflated andsubsequently deflated. The dissection balloon is formed of a chosenelastic material having a tensile less than the tensile strength of thepoints of fusion between two layers of fascia such that the dissectionballoon fails prior to achieving pressures that would destroy theanatomic boundaries of the fascial cleft such that a working space isdemonstrated not created. See FIG. 8. The dissection balloon is formedof a thin walled elastic member with no inherent predetermined inflatedshape. The balloon easily expands in all directions when not containedby a delimiting vessel or the like. When positioned within a fascialcleft, expansion of the balloon is shaped by the inherent dimensions ofthe anatomy of the fascial cleft. Accordingly, the dissection balloon isformed of a material capable of generating a force greater than theresistance of the loose areaolar tissue 16 between the two layers offascia but lesser than the force generated by the integrity of thelayers of fascia themselves or the anatomic fusion points of thoselayers.

[0067] Additionally, the surgical apparatus includes a gripping handle50. the gripping handle is coupled to the applicator at the openproximal end 26 thereof. The gripping handle includes a thumb engagingrecess 52 which corresponds to the introducing flange for allowing auser to judge the orientation of the introducing flange during use ofthe apparatus.

[0068] Further, a hollow introducing rod 60 is provided. The introducingrod is slideably positioned within the applicator 20. The rod includes afirst end 62 terminating in a concave surface 64 positioned adjacent thedissection balloon for positioning the dissection balloon exterior theapplicator to within an anatomic space for subsequent inflation anddeflation. The introducing rod also has a second end 66 extendingexterior the proximal end of the applicator. In use, the applicator'shollow tube body member 22 may be slide completely away from theintroducer rod.

[0069] Finally, the preferred embodiment of the present inventionincludes a fill tube 70. The fill tube extends through the hollowintroducing rod to the dissection balloon and is operably associatedwith the dissection balloon for inflating and deflating.

[0070] As an alternate embodiment of the present invention, themalleable introducing flange may include a luminescent material 80disposed about the peripheral edge 82 thereof for providing work areaillumination. See FIG. 4.

[0071] In use, once the flange has guided the applicator to within afascial cleft, the introducer rod is utilized to deploy the dissectionballoon to within a fascial cleft. The applicator is slidably removedfrom introducer rod and the fascial cleft leaving the inflatabledissection balloon within in the cleft. The fill tube is used to inflatethe dissection balloon with air, gas, or other suitable solution such assaline, until the limits of the fascial cleft have been reached anddemonstrated. The introducing rod remains such that its concave face iswithin the fascial cleft is whereby its first end is in the openincision to prevent the inflatable device from extruding from within theaccess incision. See FIG. 8. Finally the device is deflated and removed.

[0072] As to the manner of usage and operation of the present invention,one such preferred method of use, endoscopically assisted componentsseparation technique for ventral hernia repair, may be described.Assuming the apparatus has been assembled as in FIG. 10, the procedureis begun with the human patient placed in the supine position, with theentire abdomen prepped and draped in sterile fashion. The patient havingbeen placed under a general anesthesia, an incision is made(approximately two to three centimeters long) over the lower to mid,lateral abdominal wall. This incision is aligned with the para medianline along the nipple or mid clavicular position. The incision is madethrough the skin and subcutaneous fat and deepened through two layers ofsuperficial fascia until the deep fascia of the external oblique muscleis exposed. This is incised under direct vision one centimeter lateralto the anatomic landmark known as the semi lunar line (lateral border ofthe rectus abdominis muscle). The open distal end of the device is nextinserted into the fascial cleft between the external oblique andinternal oblique which has been exposed by the described opendissection. The introducing flange's malleable spoonbill shaped endallows for placement into the fascial cleft without inadvertentlystraying from the desired anatomic space. Once inserted into the cleft,the introducing rod of the device is used to deliver the elasticdissection balloon into the fascial cleft. The applicator is thenremoved from the cleft and the elastic balloon member is held inposition with the introducing rod to prevent it from backing out of thewound as expansion of the balloon is begun. The elastic balloon isinflated with saline or air. The shape of the dissection balloon isdetermined solely by the dimensions of the anatomic cleft. The balloonis inflated until it reaches the ligaments or anatomic boundaries of theinter-oblique muscle cleft. This is comprised of the semi lunar linemedially, inguinal canal inferiorly, seventh costal interspacesuperiorly, and the para spinous line posteriorly. Once expansion tothese boundaries is observed, additional inflation of fluid or air willnot dissect past these stated boundaries. The contra lateral side is theoperated upon in the same fashion. With the fascial cleft dissectioncomplete the dissection balloons can be left in the inflated positionfor a period of immediate tissue expansion. This helps to undo thecontraction of the lateral abdominal wall that takes place in ventralhernia formation. Attention is then turned to the abdominal midlinedefect. It can be approached through a laparoscopic or open surgicaltechnique depending on the condition of the overlying tissues and otherpatient and hernia related considerations. In instances where poorquality skin and soft tissue coverage exists, it is excised at this timein an elliptical fashion, as part of the exposure of the underlyinghernia sac. Depending on whether there has been a history ofincarceration of intestines in the hernia, the sac may require openingand resection followed by lysis of intestinal adhesions. Now thatpreparations are complete for repair of the midline linea alba, theballoon dissectors are deflated and removed. Endoscopic telescopes arethen inserted into the oblique muscle fascial clefts and laparoscopiccautery spatulas are used to divide the external oblique fascia onecentimeter lateral to the semi lunar line. The length of the fascialrelaxing incision depends on the size of the hernia defect and thereforethe need for rectus mobilization. In very large hernias the fascialrelease extends from above the costal margin to the inguinal canalbelow. Now with the fascial cleft balloon dissection of the externaloblique from the internal oblique, and associated immediate tissueexpansion, the endoscopic release of the external oblique fascia allowsfor mobilization of the rectus muscles to the midline without unduetension. The closure of the midline rectus fascia with a runningpermanent suture is accomplished at this time. Wound closure isperformed to complete the procedure.

[0073] Endoscopic components separation technique for ventral herniarepair makes use of the present invention to perform fascial cleftsurgery in a quick, easy, accurate and complete fashion through aminimal incision. It also allows for immediate tissue expansion tolesson tension on the midline closure. Use of the device for minimallyinvasive skin sparing mastectomy exemplifies another use of the devicedemonstration of the dimensions and size of a particular anatomicfascial cleft. The procedure is begun with a one centimeter incision onthe lateral aspect of the inframammary fold crease. Open dissection isperformed to the retro mammary fascial cleft. The device is insertedmaking use of the spoonbill distal end to insert the applicator into thecleft. Once the introducer has delivered the elastic balloon into theretro mammary space, the balloon is inflated until expansion is observedto have stopped at the anatomic boundaries of the circum mammaryligament. The balloon is then deflated and the mastectomy is begun witha circum areaolar incision. The overlying skin is dissected away fromthe breast tissue in an ongoing circular fashion. The open dissectioncontinues until the attachment of the skin to the chest wall isapproached. This is the critical point in the procedure as every bit ofthe breast gland must be removed without overshooting the circum mammaryligament. Next the balloon which has already performed a dissectionunder the breast to the boundaries of the circum mammary ligament ispartially inflated. This allows connection of the two dissection planes(retro mammary cleft and subcutaneous mastectomy plane) at the parasternal location through open dissection. The balloon is then deflatedand removed before the connecting of the two planes of dissection iscompleted by open dissection in circular fashion; starting first in thedirection of the inframammary fold, followed by dissection towards thesuperior aspect of the breast, saving the lateral aspect for last. Thelateral boundary of the breast's attachment to the chest is the mostcritical and yet most indistinct. It is in this region that the device'sdissection footprint is therefore most helpful. Since all otherattachments of the breast to the skin and chest wall have been dividedthe breast can be delivered out through the circum areaolar incision.The surgeon then identifies the last remaining tissue that requiresdivision through bi-manual palpation of the tissue bridge between thesub cutaneous dissection and device created sub glandular dissection.This tissue is carefully divided and the mastectomy is complete. Anen-block axillary node dissection is carried out through the circumareaolar incision to complete the modified radical mastectomy. Breastreconstruction follows directly, using a TRAM flap or implant covered bya Latissimus Dorsi flap.

[0074] With respect to the above description then, it is to be realizedthat the optimum dimensional relationships for the parts of theinvention, to include variations in size, materials, shape, form,function and manner of operation, assembly and use, are deemed readilyapparent and obvious to one skilled in the art, and all equivalentrelationships to those illustrated in the drawings and described in thespecification are intended to be encompassed by the present invention.

[0075] Therefore, the foregoing is considered as illustrative only ofthe principles of the invention. Further, since numerous modificationsand changes will readily occur to those skilled in the art, it is notdesired to limit the invention to the exact construction and operationshown and described, and accordingly, all suitable modifications andequivalents may be resorted to, falling within the scope of theinvention.

What is claimed as being new and desired to be protected by Letters Patent of the United States is as follows:
 1. A new and improved surgical apparatus for use in fascial cleft surgery and adapted to perform blunt dissection between two layers of anatomically named fascia, the dissection extending to the limits of anatomic space defined by fusion of said two layers of fascia in a minimally invasive manner comprising, in combination: an applicator, the applicator is formed of a hollow tube body member having an open proximal end and an open distal end; a introducing flange formed at the distal end of the applicator, said introducing flange having a spoonbill-like shape; an elastic dissection balloon movably positioned within said applicator at the distal end thereof adjacent said introducing flange wherein said dissection balloon being reversibly expandable between a deflated condition and an expanded condition and wherein said dissection balloon being movable from a first storage position within the hollow tube body of the applicator to a position exterior thereof and wherein said dissection balloon formed of a chosen elastic material having a tensile less than the tensile strength of the points of fusion between two layers of fascia such that the dissection balloon fails prior to achieving pressures that would destroy the anatomic boundaries of the fascial cleft such that a working space is demonstrated not created; a gripping handle coupled to said applicator at the open proximal end thereof, said gripping handle including a thumb engaging recess corresponding to the introducing flange for allowing a user to judge the orientation of the introducing flange during use of the apparatus; a hollow introducing rod slideably positioned within said applicator, said introducing rod having a first end terminating in a concave surface positioned adjacent the dissection balloon for positioning said dissection balloon exterior said applicator to within an anatomic space for subsequent inflation and deflation, said introducing rod having a second end extending exterior the proximal end of said applicator; and a fill tube extending through said hollow introducing rod to said dissection balloon and operably associated therewith for inflating and deflating said dissection balloon.
 2. The new and improved surgical apparatus of claim 1 wherein the introducing flange is malleable.
 3. The new and improved surgical apparatus of claim 1 wherein the malleable introducing flange includes a luminescent material disposed about the peripheral edge thereof.
 4. A new and improved surgical apparatus for use in fascial cleft surgery and adapted to perform blunt dissection between two layers of anatomically named fascia, the dissection extending to the limits of anatomic space defined by fusion of said two layers of fascia in a mimmally invasive manner comprising, in combination: an applicator; an elastic dissection balloon movably positioned within said applicator; and a hollow introducing rod slideably positioned within said applicator for positioning said dissection balloon exterior said applicator to within an anatomic space for subsequent inflation and deflation.
 5. The new and improved surgical apparatus of claim 4 and further including a fill tube extending through said hollow introducing rod to said dissection balloon and operably associated therewith for inflating and deflating said dissection balloon.
 6. The new and improved surgical apparatus of claim 5 wherein the applicator is formed of a hollow tube body member having an open proximal end and an open distal end.
 7. The new and improved surgical apparatus of claim 6 wherein a malleable introducing flange is formed at the distal end of the applicator, said introducing flange having a spoonbill-like shape.
 8. The new and improved surgical apparatus of claim 7 wherein an elastic dissection balloon is movably positioned within said applicator at the distal end thereof adjacent said introducing flange wherein said dissection balloon being reversibly expandable between a deflated condition and an expanded condition and wherein said dissection balloon being movable from a first storage position within the hollow tube body of the applicator to a position exterior thereof and wherein said dissection balloon formed of a chosen elastic material having a tensile less than the tensile strength of the points of fusion between two layers of fascia such that the dissection balloon fails prior to achieving pressures that would destroy the anatomic boundaries of the fascial cleft such that a working space is demonstrated not created.
 9. The new and improved surgical apparatus of claim 8 and further including a gripping handle coupled to said applicator at the open proximal end thereof, said gripping handle including a thumb engaging recess corresponding to the introducing flange for allowing a user to judge the orientation of the introducing flange during use of the apparatus.
 10. The new and improved surgical apparatus of claim 9 and further including a hollow introducing rod slideably positioned within said applicator, said introducing rod having a first end terminating in a concave surface positioned adjacent the dissection balloon for positioning said dissection balloon exterior said applicator to within an anatomic space for subsequent inflation and deflation, said introducing rod having a second end extending exterior the proximal end of said applicator.
 11. A new and improved surgical apparatus for use in fascial cleft surgery and adapted to perform blunt dissection between two layers of anatomically named fascia, the dissection extending to the limits of anatomic space defined by fusion of said two layers of fascia in a minimally invasive manner comprising, in combination: an applicator formed of an open ended hollow tube body member; a malleable introducing flange formed at the distal end of the applicator; an elastic dissection balloon movably positioned within said applicator adjacent said introducing flange wherein said dissection balloon being reversibly expandable between a deflated condition and an expanded condition and wherein said dissection balloon being movable from a first storage position within the hollow tube body of the applicator to a position exterior thereof and wherein said dissection balloon formed of a chosen elastic material having a tensile less than the tensile strength of the points of fusion between two layers of fascia such that the dissection balloon fails prior to achieving pressures that would destroy the anatomic boundaries of the fascial cleft such that a working space is demonstrated not created; a hollow introducing rod slideably positioned within said applicator for positioning said dissection balloon exterior said applicator to within an anatomic space for subsequent inflation and deflation, said introducing rod having a second end extending exterior the proximal end of said applicator for amnual manipulation; and a fill tube extending through said hollow introducing rod to said dissection balloon and operably associated therewith for inflating and deflating said dissection balloon.
 12. The new and improved surgical apparatus of claim 2 wherein the malleable introducing flange includes a luminescent material disposed about the peripheral edge thereof.
 13. The new and improved surgical apparatus of claim 4 wherein said dissection balloon is formed of a chosen elastic material having a tensile less than the tensile strength of the points of fusion between two layers of fascia such that the dissection balloon fails prior to achieving pressures that would destroy the anatomic boundaries of the fascial cleft such that a working space is demonstrated not created. 